Pavlik Harness

FDA 510(k) K780375 · Biomet, Inc.

Substantially Equivalent

510(k) numberK780375

Submission

Device name
Pavlik Harness
Applicant
Biomet, Inc.
Mchenry, IL, US
Received
March 8, 1978
Decision date
March 15, 1978
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IOZ – Splint, Abduction, Congenital Hip Dislocation
Device class
Class I (low risk)
Regulation
21 CFR 890.3665
Specialty
Physical Medicine

Other 510(k)s with product code IOZ

510(k)DeviceApplicantDecision
K830243Abduction PillowIOZ · Traditional Warm & Form, Orthopedic Materials03/08/1983SE
K823820Abduction PillowIOZ · Traditional Danek Medical, Inc.01/14/1983SE
K810557Hip Abduction SplintIOZ · Traditional Orthomedics03/13/1981SE

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Questions and answers

When was Pavlik Harness cleared by the FDA?

Pavlik Harness (K780375) received a 510(k) decision of Substantially Equivalent on March 15, 1978, 7 days after the submission was received.

What is the product code of K780375?

The FDA product code is IOZ – Splint, Abduction, Congenital Hip Dislocation, a Class I (low risk) device regulated under 21 CFR 890.3665.